Daewoong Pharmaceuticals said Tuesday it has confirmed the potency stability of its botulinum product, Nabota, under various temperatures.

Potency stability refers to the product's efficacy and safety or maintaining potency in several conditions, including room temperature, refrigeration, and freezing after diluting the drug. 

Professor Park Kui-young at Choong-Ang University School of Medicine and  Daewoong’s research team jointly conducted the study by diluting 100U/2.5ml Dilute at certain temperatures and injecting it into mice, and measured its potency by checking the three-day fatality rate.

The researchers found that after dissolution, Nabota’s potency was stable for 12 weeks, 24 weeks, and 48 weeks at room temperature ((20±5℃), refrigerated (5±3℃), and frozen (-20±5℃), respectively. Based on the results, they expected the potency to remain stable for up to two years if frozen, one-and-a-half years when refrigerated, and four months if kept at room temperature.

“Amid the popularization of botulinum toxin procedures and its potential overuse among the public, concerns are rising about the risk of using botulinum. There are already reported cases of treatment failures coming from its resistance,” Professor Park said. “We expect to reduce such worries of the botulinum toxin’s resistance by keeping up with consumer’s satisfaction by maintaining the stable potency of botulinum toxins.” 

Park Sung-soo, the head of Daewoong’s Nabota business division, said, “Daewoong’s botulinum toxin agent is an internationally proven, a high-quality product made from high-purity refining technology.”

Based on the excellence of the product approved by the strict regulators in the U.S., Europe and Canada, Daewoong will conduct additional researches to prove Nabota’s competence, Park added.